Clinical Quality Manager

Clinical Quality ManagerAre you a people leader who thrives at the intersection of quality, compliance, and patient impact? Medtronic is seeking a Clinical Quality Manager to lead and elevate clinical quality systems, compliance, and operational excellence across the Surgical organization. This role offers a unique opportunity to lead a team that plays a critical role in protecting patients, ensuring the integrity of clinical research activities, strengthening stakeholder trust, and driving quality excellence in a highly regulated environment. In this leadership role, you will develop and empower a high-performing team through clear prioritization, coaching, and readiness for audits, inspections, and quality-related assessments. You will proactively identify, assess, and escalate quality and compliance risks in a timely, decision-ready manner while ensuring adherence to applicable regulations, standards, and internal processes supporting clinical research and clinical operations. Working closely with stakeholders across the Clinical, Medical Affairs & HEPR (CMAH) organization and key cross-functional partners, you will help drive alignment, foster a culture of quality, and continuously improve processes and standards to increase efficiency, consistency, compliance, and inspection readiness. If you are energized by leading through complexity, building strong partnerships, fostering a culture of quality, and developing teams that deliver with confidence, integrity, and a patient-first mindset, this role offers meaningful scope, visibility, and impact.Responsibilities may include the following and other duties may be assigned.Lead and develop a high performing team through clear prioritization, coaching, and capability building to deliver quality outcomes at scale.Assess accuracy and quality of data submitted to outside the CMAH team including regulatory agenciesLead audit readiness by conducting and performing investigations and ensure conformance to regulations and company standard operating procedures.Documents audit observations and make recommendations for corrective and preventive action.Drive QMS/QDR (e.g., CQFR/QMR) forums and reporting by consolidating quality data, preparing review materials, and facilitating leadership discussions to inform decisions and actions.Proactively identify and manage risks and issues by assessing trends, surfacing gaps, and escalating concerns in a clear, decision ready manner.Own and improve clinical quality processes and standards by identifying opportunities to increase efficiency, consistency, and inspection readiness.Partner cross functionally with clinical, regulatory, and quality teams to resolve findings, address deficiencies, and ensure alignment on expectations.May create and maintain clinical quality assurance databases, reports, and files.Performs quality reviews and tracks corrective and preventive actions until closure.May act as an advisor on clinical quality assurance protocol, amendments and/or biological licensing agreements.May also audit operating systems, processes and procedures.May support risk management operations, including ongoing review of literature and compilation and interpretation of safety data to support product strategies.May plan and prepare report drafts for products, compliance statements, audit certifications, and safety issues for regulatory submission.May use six-sigma methodology.May provide training on GCP and current regulations for those undertaking clinical studies.Must Have: Minimum RequirementsBachelor's degree requiredMinimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.Nice to HaveKnowledge of Medtronic systemsUnderstanding of the clinical Quality and Regulatory environmentsExperience in the Medical Device Industry.For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.Physical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.?The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.U.S. Work Authorization & SponsorshipAt Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.Recruitment Fraud AlertWe are aware of phishing scams targeting job seekers. Please keep the following in mind:Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at View email address on click.appcast.io & CompensationMedtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.Salary ranges for U.S (excl. PR) locations (USD):$131,200.00 - $196,800.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.Further details are available at the link below:Medtronic benefits and compensation plansIt is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal